Closure device

ABSTRACT

A device for closing an opening in a wall of a body lumen includes a closure element with a first flange and a second flange. Both the first flange and the second flange may have a delivery cross-sectional dimension and a deployed cross-sectional dimension. The device for closing an opening further includes a first coupler element disposed on the first flange and a second coupler element disposed on the second flange, the first and second coupler elements cooperating to couple the first flange to the second flange.

CROSS REFERENCE

This application is a continuation of U.S. patent application Ser. No.12/608,769, filed on Oct. 29, 2009, which claims the benefit of, andpriority to, U.S. Provisional Patent Application Ser. No. 61/109,822,filed on Oct. 30, 2008 and entitled “CLOSURE DEVICE,” and Ser. No.61/143,748, filed on Jan. 9, 2009 and entitled “CLOSURE DEVICE,” all ofwhich are incorporated in their entirety herein by this reference.

BACKGROUND

1. The Field of the Invention

The present disclosure relates generally to systems, devices, andmethods for blocking an opening in body lumens. More particularly, thepresent disclosure relates to techniques for percutaneous closure ofarterial and venous puncture sites, which are usually accessed through atissue tract.

2. The Relevant Technology

A number of diagnostic and interventional vascular procedures are nowperformed transluminally. A catheter is introduced to the vascularsystem at a convenient access location and guided through the vascularsystem to a target location using established techniques. Suchprocedures require vascular access, which is usually established duringthe well-known Seldinger technique. Vascular access is generallyprovided through an introducer sheath, which is positioned to extendfrom outside the patient body into the vascular lumen. When vascularaccess is no longer required, the introducer sheath is removed andbleeding at the puncture site stopped.

One common approach for providing hemostasis (the cessation of bleeding)is to apply external force near and upstream from the puncture site,typically by manual compression. This approach suffers from a number ofdisadvantages. For example, the manual compression procedure is timeconsuming, frequently requiring one-half hour or more of compressionbefore hemostasis is achieved. Additionally, such compression techniquesrely on clot formation, which can be delayed until anticoagulants usedin vascular therapy procedures (such as for heart attacks, stentdeployment, non-optimal PTCA results, and the like) wear off. Theanticoagulants may take two to four hours to wear off, therebyincreasing the time required before completion of the manual compressionprocedure.

Further, the manual compression procedure is uncomfortable for thepatient and frequently requires analgesics to be tolerable. Moreover,the application of excessive pressure can at times totally occlude theunderlying blood vessel, resulting in ischemia and/or thrombosis.Following manual compression, the patient typically remains recumbentfrom four to as much as twelve hours or more under close observation toassure continued hemostasis. During this time, renewed bleeding mayoccur, resulting in blood loss through the tract, hematoma and/orpseudo-aneurysm formation, as well as arteriovenous fistula formation.These complications may require blood transfusion and/or surgicalintervention.

The incidence of complications from the manual compression procedureincreases when the size of the introducer sheath grows larger, and/orwhen the patient is anticoagulated. The compression technique forarterial closure can be risky, and is expensive and onerous to thepatient. Although the risk of complications can be reduced by usinghighly trained individuals, dedicating such personnel to this task isboth expensive and inefficient. Nonetheless, as the number and efficacyof translumenally performed diagnostic and interventional vascularprocedures increases, the number of patients requiring effectivehemostasis for a vascular puncture continues to increase.

To overcome the problems associated with manual compression, the use ofbioabsorbable sealing bodies is one example approach that has beenproposed. Generally, this example approach relies on the placement of athrombogenic and bioabsorbable material, such as collagen, at thesuperficial arterial wall over the puncture site. While potentiallyeffective, this approach suffers from a number of problems. For example,bioabsorbable sealing bodies may lack a solid mechanical attachment ofthe sealing body to the tissue. Due to the lack of a solid mechanicalattachment, the sealing body can wander within the tissue tract or moveout of the puncture site, thus causing late bleeds. Conversely, if thesealing body wanders and intrudes too far into the arterial lumen, dueto the lack of a solid mechanical attachment, intravascular clots and/orcollagen pieces with thrombus attached can form and embolize downstream,causing vascular occlusion.

In addition to not having a solid mechanical attachment to the tissue,the sealing bodies may rely upon expandable materials to achievehemostasis. Again, the expandable materials lack the security of a hardmechanical closure, thus potentially causing late bleeds and prolonginghemostasis.

BRIEF SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter. Embodiments of the present disclosure provide systems, methodsand devices for closing an opening in tissue. Embodiments of thedisclosure can be configured to close an opening within a body lumen.

In one example embodiment, a device for closing an opening in a wall ofa body lumen may include a closure element with a first flange and asecond flange. Both the first flange and the second flange have adelivery cross-sectional dimension and a deployed cross-sectionaldimension. The device further includes a first coupler element disposedon the first flange and a second coupler element disposed on the secondflange, the first and second coupler elements cooperating to couple thefirst flange to the second flange.

In another example embodiment, a closure element for closing an openingin a body lumen includes a proximal flange with a first coupler elementand a distal flange with a second coupler element. The closure elementmay also include a pull cord that is operatively associated with thedistal flange such that the second coupler element may be coupled to thefirst coupler element by pulling the pull cord.

Another example embodiment includes a closure element that has adelivery configuration and a deployed configuration and is used to closean opening in a wall of a body lumen. The closure element includes afirst flange with a delivery configuration and a deployed configurationsuch that the first flange can pass through the opening in the wall ofthe body lumen when in the delivery configuration, but not when in thedeployed configuration. The closure element further includes a secondflange having a delivery configuration and a deployed configuration,wherein the second flange cannot pass through the opening in the wall ofthe body lumen when in the deployed configuration. Moreover, the closureelement may include a coupler portion positioned between the firstflange and the second flange, the coupler portion having across-sectional dimension substantially equal to or smaller than theopening.

A further embodiment includes a system for closing an opening in a bodylumen that includes a closure element, an actuator coupled to theclosure element, and a handle assembly. The handle assembly may includea handle element operatively associated with a hub member such that theactuator moves the closure element from a delivery configuration to adeployed configuration upon rotation of the handle element.

Another embodiment of the invention includes a method of closing anopening in tissue that includes inserting a closure device into anopening formed in tissue. Applying a force to the actuator to change theclosure element from a first configuration to a second configuration.

These and other advantages and features of the present disclosure willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of the disclosure as set forthhereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of thepresent disclosure, a more particular description will be rendered byreference to specific embodiments which are illustrated in the appendeddrawings. It is appreciated that these drawings depict only typicalembodiments of the disclosure and are therefore not to be consideredlimiting of its scope. The embodiments will be described and explainedwith additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 illustrates an example embodiment of a closure element inaccordance with the present disclosure;

FIGS. 2 and 3 illustrate example components of an example embodiment ofthe closure element of FIG. 1;

FIG. 4 is a partial cross-sectional view of a delivery system and theclosure element of FIG. 1;

FIG. 5A is an illustration of the closure element of FIG. 1 partiallydeployed;

FIG. 5B is an illustration of the closure element of FIG. 1 fullydeployed; and

FIG. 6 is a flow chart showing an example method of closing an openingin tissue in accordance with the present disclosure.

DETAILED DESCRIPTION

In accordance with the present disclosure, there is provided closuredevices configured to close an opening in tissue. The closure devicesdescribed herein may be formed of a bioabsorbable material or may beformed of a biocompatible material. It is further contemplated that theclosure device may be coated with a covering membrane and/or anotherbiocompatible coating as will be described in greater detail below. Inone embodiment, the closure device may be configured to be receivedwithin and deployed from the lumen of a medical sheath, for example, aphysician may utilize a 6 French sheath. However, it can be understoodthat embodiments of the closure device may be configured to be receivedwithin multiple sizes and configurations of sheaths and should not belimited to the example above and will accommodate newer and yet to bedeveloped endoluminal techniques including venous techniques.

Moving now to FIGS. 1 through 5B, an example closure device pursuant toembodiments of the present disclosure will be discussed. In particular,FIG. 1 illustrates an example closure element 300. The closure element300 may include a proximal flange 302 and a distal flange 304. Theproximal flange 302 may include a first coupler 306 while the distalflange 304 may include a second coupler 308. In at least one exampleembodiment, the second coupler 308 may include friction elements 310, asillustrated in FIG. 1. In further embodiments, the first coupler 306 andsecond coupler 308 may be configured to couple together in any of avariety of configurations, such as by friction, threading, snap-fit,tongue-and-groove, similar coupling configurations, or combinationsthereof. In a yet further embodiment, once the second coupler 308 isinserted into the first coupler 306, a pin or other elongate member maybe inserted through the second coupler 308 to force the second coupler308 outward and into more secure contact with the first coupler 306.

Briefly, in operation, the closure element 300 may be inserted into anopening in a body lumen in a delivery configuration. The distal flange304 may then be deployed within the body lumen and the proximal flange302 may be deployed outside the body lumen. The proximal flange 302 andthe distal flange 304 may then be coupled or otherwise joined togetherthrough the opening in the body lumen. In one example, the secondcoupler 308 is pressed into the first coupler 306 and locked into placewith friction elements 310 that allow the second coupler 308 to bepressed into the first coupler 306 but do not allow the second coupler308 to be released from the first coupler 306.

The closure element 300, illustrated in FIG. 1, may have variouscharacteristics and configurations. For example, one way in which theclosure element 300 may vary is the type of material used to make theclosure element 300. In one embodiment the closure element 300 may bemanufactured from a bioabsorbable, bioresorbable, bioerodible, orbiodegradable material. Examples of suitable materials for use aremetals, metal alloys, polymers, or combinations thereof that decomposeor biodegrade in a biological environment such as within a body lumen.For example, and not by limitation, suitable bioabsorbable materials mayinclude magnesium, zinc, iron, silicon, zinc titanium, magnesiumlithium, of colic acid (PGA), polyhydroxybutyric acid, polyL-Lactic acid(PLLA), poly dl-lactic acid (PDLLA), polydilactidel glycolide acid,polydilactid acid, PolyDL Lactide-co-gycolide, Polylactic acid,Polyhydroxyalkanoates, polylactic acid-co-caprolactone, polylacticacid-co-Chitosan, poly-phosphazenes, poly-anhydrides, degradablepoly-urethanes, biodegradable poly-carbonates, biodegradable ceramicssuch as those based on tricalcium phosphate or hydroxyapatite, analogousmaterials, co-polymers thereof, derivatives thereof, and anycombinations thereof.

In addition to the various types of materials that may be used tomanufacture the closure element 300, the closure element 300 may includeadditional material properties that may be useful. For example, theclosure element 300 may be covered with a flexible membrane to aid insealing the opening. The flexible membrane may be formed of a flexiblebio-compatible or bioabsorbable material such as any of those that aredescribed above. Moreover, the closure element 300 may further include abeneficial agent either disposed thereon as a coating or integrallyformed within the material of the closure element 300. The beneficialagent may be configured to aid in healing and/or reduce the potentialfor infection.

Moreover, the closure element 300 may include additional elements tohelp a user place the closure element 300 within a body lumen. Forexample, the closure component 300 may further include a radiopaquemarker or radiopaque coating in order to aid the user in positioning theclosure element 100 within the puncture site of the body lumen. Theradiopaque marker may be formed within the wall of the body of the firstor second flange 302, 304 in the form of a rivet. In a furtherembodiment, a radiopaque coating may be disposed on the closure element300 as a thin coating of radiopaque metal such as gold, tantalum,platinum, iridium, similar metals, or combinations thereof. In a yetfurther embodiment, the radiopaque coating may comprise an iodinecontained polymer such as polytyrosine carbonate with iodine.

In addition to material aspects of the closure element 300, theconfiguration of the closure device 300 may vary from one embodiment tothe next. For example, the cross-sectional configuration of the proximaland distal flanges 302 and 304 may vary from one embodiment to the next.In one example embodiment, the proximal and distal flanges 302 and 304may have a substantially circular or disc-like shape/configuration, asillustrated in FIG. 1. In other examples, the proximal and distalflanges 302 and 304 may have various other shapes or configurations,such as square, rectangular, oval, or any other cross-sectionalconfiguration. Moreover, the proximal flange 302 and the distal flange304 may have differing shapes or configurations. In a yet furtherembodiment, the proximal flange 302 and the distal flange 304 may berotationally offset with respect to each other.

Just as the shape and configuration of the proximal flange 302 and thedistal flange 304 may vary, so too may the cross-sectional profile varyfrom one embodiment to the next. As illustrated in FIG. 1, the proximalflange 302 and the distal flange 304 have a T-shaped cross-sectionalprofile with a substantially flat horizontal cross-bar section. In otherexample embodiments, the cross-bar section may further include ridges orprotrusions that may be used to grip tissue and further anchor theclosure element 300 within an opening in a body lumen.

Moreover, the second coupler 308 and first coupler 306 may have anyconfiguration for joining or coupling the proximal flange 302 and thedistal flange 304 together. For example, in one embodiment, the firstcoupler 306 and second coupler 308 may couple together through a hookand anchor configuration. In a further embodiment, the first coupler 306and second coupler 308 may have corresponding internal and externalthreads and may screw together. In a yet further embodiment, the firstcoupler 306 and second coupler 308 may have any other configuration thatcould be used to join or couple the proximal flange 302 to the distalflange 304. Moreover, in other example embodiments, the proximal flange302 and the distal flange 304 may be made from the same piece ofmaterial or permanently joined together prior to deployment.

FIG. 2 illustrates an isolated view of an example distal flange 304. Asillustrated in FIG. 2, the distal flange 304 may have a distal end 304Aand a proximal end 304B. Moreover, the distal flange 304 may include asecond coupler 308 with a plurality of friction elements 310 located onthe second coupler 308. In one example embodiment, the distal flange 304may further include a pull cord 312. The distal flange 304 may vary fromone embodiment to the next. For example, the friction elements 310 mayvary from one embodiment to the next. In one example embodiment,illustrated in FIG. 2, the friction elements 310 may be equally spacedand arranged on the second coupler 308. In a further example embodiment,the friction elements 310 may be randomly arranged. Moreover, in otherembodiments, there may be only one friction element 310 instead of aplurality of friction elements 310.

Another way in which the friction elements 310 may vary is the type offriction elements 310 used. For example, the friction elements 310 inone example embodiment may be o-ring type structures that are configuredto have a tolerance fit with the first coupler 306 of the proximalflange 302. In another example, the friction elements 310 may includeteeth or ramps which could be complimentary to teeth or ramps disposedwithin the first coupler 306, thereby, causing the proximal flange 302and the distal flange 304 to be locked together.

FIG. 3 illustrates an isolated view of an example of the proximal flange302. The proximal flange 302 may include a proximal end 302 a, a distalend 302 b and a first coupler 306 that includes a passage 314. Theproximal flange 302 may vary from one embodiment to the next. Forexample, the passage 314 in the first coupler 306 may vary. Asillustrated in FIG. 3, the passage 314 may have a constantcross-sectional dimension. In other example embodiments, thecross-sectional dimension of the passage 314 may vary. For example, thecross-sectional dimension may become smaller moving from the distal end302 b to the proximal end 302 a of the proximal flange 302. In this way,the second coupler 308 on the distal flange 304 may be configured towedge or otherwise interface with the narrowing passage 314.

The material of the proximal flange 302 and the distal flange 304 mayvary from one embodiment to the next. The proximal flange 302 and thedistal flange 304 may be generally constructed of a flexiblebiocompatible material, such as a bioabsorbable material. Examples ofsuitable materials are described in more detail above.

FIGS. 4 through 5B illustrate example embodiments of a closure device330 that employs the closure element 300. As shown in FIG. 4, theproximal flange 302 and the distal flange 304 may be configured suchthat they are able to collapse, bend, or flex at approximately rightangles with respect to the first coupler 306 and second coupler 308respectively, thus forming a delivery configuration. While in thedelivery configuration, the proximal flange 302 and the distal flange304 may be inserted within a delivery tube 316. The delivery tube 316may have a passage 332 that has a cross-sectional dimension that allowsthe proximal flange 302 and the distal flange 304 to be inserted withinthe passage 332. Moreover, the closure device may include a first pusher318 and a second pusher 320, with the first pusher 318 operativelyassociated with the distal flange 304, and the second pusher 320operatively associated with the proximal flange 302.

The configuration of the closure device 330 may vary from one embodimentto the next. For example, and as illustrated in FIG. 4, the first pusher318 may be configured to extend through the passage 314 of the proximalflange 302 and interface with or otherwise apply a force to the distalflange 304. The second pusher 320 may be configured with a largercross-sectional dimension such that it cannot pass through the passage314 of the proximal flange 302, and thus, the second pusher 320 caninterface with or otherwise apply a force to the proximal flange 302.

While positioned within the delivery tube 316, the proximal flange 302and the distal flange 304 may be uncoupled together. When the proximaland distal flanges 302 and 304 are not connected, the first and secondpushers 318 and 320 can move the proximal flange 302 and distal flange304 independent from one another to advance or retract the proximalflange 302 and/or distal flange 304. In further embodiments, theproximal flange 302 and the distal flange 304 may be coupled togetherduring the delivery of the closure element 300 within the opening in thebody lumen. When the proximal and distal flanges are coupled togetherwhile in the delivery tube 316, a single pusher may be used and theremay not be a need for a first and second pusher. For example, the secondpusher 320 alone may move and control both the proximal and distalflanges 302 and 304.

FIGS. 5A and 5B illustrate an example implementation of the closuredevice 330. In particular, FIG. 5A illustrates the deployedconfiguration of the distal flange 304 within the body lumen. In orderto deploy the distal flange 304, delivery tube 316 is inserted into anopening located in the body lumen wall 322. At that point, the firstpusher 318 may apply a force in the distal direction on the distalflange 304. Once the distal flange 304 leaves or exits the delivery tube316, the distal flange 304 may elastically or otherwise move from theu-shape configuration or delivery configuration into a deployedconfiguration, as shown in FIG. 5A.

Once deployed, the distal flange 304 may then be attached or coupled tothe proximal flange 302, if not already coupled. In one exampleembodiment, this attachment may occur by way of the pull-cord 312. Forexample, a user of the closure device 330 may pull the pull-cord 312 ina proximal direction, thus pulling the distal flange 304 relative to andtowards the proximal flange 302. In this way, the second coupler 308located on the distal flange 304 may be pulled into the first coupler306 located on the proximal flange 302. In further embodiments, thedeployment of the closure element 300 could still move forward at thispoint without having connected the proximal flange 302 to the distalflange 304. In further embodiments, the pull-cord 312 can be coupled toan automated and/or powered tensioning device configured to provide adesired tension to the pull-cord 312. In yet further embodiments, thepull-cord 312 may be sufficiently rigid to transfer both distal andproximal forces to the closure element 300. In additional embodiments,the closure element 300 and any components thereof may be coupled to aclosure system configured to deploy the closure element 300 uponmanipulation of the closure system by a user.

The spacing between the proximal flange 302 and distal flange 304 isadjustable depending upon the amount of force applied to the distalflange 304 by the pull-cord 312 and depending on the thickness of thebody lumen wall where the closure element 300 is being deployed, therebyenabling the closure element 300 to be adjusted for various anatomies.As will be described in greater detail below, a charge of hemostaticmaterial may be disposed proximal to the deployed closure element 300,such as within the tissue tract and/or against the outer surface of thedeployed proximal flange 302 and body lumen, to further enhance sealing.

Moving now to FIG. 5B, the proximal flange 302 is shown in a deployedconfiguration outside of the delivery tube 316. In order for theproximal flange 302 to achieve the deployed configuration, the secondpusher 320 may apply a force in the distal direction upon the proximalflange 302. While the second pusher 320 applies a force in the distaldirection on the proximal flange 302, the delivery tube 316 may bepulled in the proximal direction such that the proximal flange 302 exitsthe delivery tube 316. Upon exiting the delivery tube 316, the proximalflange 302 may move elastically or otherwise from the deliveryconfiguration to the deployed configuration such that the proximalflange 302 extends outward.

If the proximal flange 302 and the distal flange 304 have not yet beencoupled together at this point, then the proximal flange 302 and thedistal closure element may be pressed together such that the secondcoupler 308 located on the distal flange 304 may be pressed into thefirst coupler 306 located on the proximal flange 302. This may be doneby use of a pull-cord 312, the first pusher 318, and/or second pusher320, as discussed above. Once the proximal flange 302 and the distalflange 304 are coupled together and surround the lumen wall 322, thedelivery tube 316 along with the first pusher 318 and second pusher 320may be removed from the patient, while the closure element 300 remainsto at least partially occlude or block the opening in the body lumenwall 322.

The closure device discussed with the various example embodiments of thepresent invention may include various other configurations. For example,any configuration of the closure device that includes a closure elementthat is able to anchor on the inside surface of the body lumen wall aswell as on the outside surface of the body lumen wall (i.e. sandwich thewall of the body lumen between two portions of the closure element) maybe used with the closure device.

As briefly mentioned above, the closure device 330 may include ahemostatic agent. For example, the passage 332 may be at least partiallyfilled with the hemostatic agent in the space between the proximalflange 302 and the distal flange 304 such that as the closure element300 is deployed, the hemostatic agent may be deployed proximate theopening in the tissue.

The hemostatic agent may be any material that is known to aid in thehealing of the body lumen wall as well as to cause the cessation ofbleeding. Moreover, the hemostatic agent may contain any material oragent that may be used to avoid infection. Suitable hemostatic materialsfor any of the embodiments described above may include chitosan,collagen, thrombin, PEG or other biocompatible materials. In oneembodiment, chitosan may be utilized. The chitosan hemostaticcomposition can provide a strong clotting action to seal a hole,puncture, incision, or any other bleeding site to promote enhancedhealing of the bleeding site and reduce opportunities for infection.Additionally, the chitosan hemostatic composition can be configured toswell in the presence of blood to form a hemostatic barrier that coversor otherwise plugs the bleeding site and/or aids the hemostasis of thepercutaneous tissue tract.

Chitosan is a polycationic polymer derived from chitin, which can alsobe used as described herein. Chitosan has a positive charge from primaryamine groups that can interact with the negative charge of the lipidspresent on cell surfaces, such as blood cells. This electrostaticinteraction has been identified as an aspect of the hemostaticproperties of chitosan. Dry chitosan compositions can have increasedhemostatic properties by increasing surface area, and thereby thecontact area with blood. Processing methods, such as freeze drying,puffing, foaming, sponging, ballooning, combinations thereof, or thelike, can be used to provide a porous, open cellular, or closed cellularstructure with increased surface area. In addition to chitosan and/orchitin, other polymers having N-acetylglucosamines and N-glucosamines,such as poly-beta-1→4-N-acetylglucosamines with or without one or moremonosaccharides being deacetylated and poly-beta-1→4-N-glucosamines, andderivatives thereof.

The chitosan or other similar polymer used in various embodiments of thepresent invention may be purified to facilitate use in a medical deviceand or used within the body of a subject. This may include beingpurified to remove proteins or other organic and/or inorganiccontaminants. Such purification and processing of chitosan is well knownin the art. Accordingly, the chitosan or other similar polymer can beconsidered to be biocompatible, immunoneutral, and/or generallyrecognized as safe for use with or within a subject, such as a human orother animal.

Accordingly, the previous figures and the corresponding text provide anumber of different components and systems that may be used to close anopening in a body lumen. In addition to the foregoing, other exampleembodiments may also be described in terms of flowcharts comprising oneor more acts in a method for accomplishing a particular result. Forexample, FIG. 6 illustrates a method 600 of closing an opening intissue. The acts of method 600 are discussed more fully below withrespect to the disclosures of FIGS. 1-5.

For example, FIG. 6 shows that a method in accordance with an exampleimplementation of the invention may include inserting 602 a closuredevice into an opening in a body lumen wall. Inserting a closure devicemay involve inserting a closure device into an opening formed in tissue,the closure device including a delivery tube, an actuator, and a closureelement, the closure element defined by a body having a proximalportion, a distal portion and a waist. For example, as shown in FIG. 5A,the closure element 300 may be inserted through the proximal lumen wall322 or through an introducer that has already been implanted/positionedthrough the lumen wall.

After the closure device is inserted into an opening, a force may beapplied 604 to the actuator to move a first portion of a closure elementfrom a first configuration to a second configuration. Applying a forcemay involve applying a force to the actuator to move the distal portionof the closure element from a first configuration toward a secondconfiguration, wherein in the second configuration, portions of theclosure element protrude from the body. For example, as shown in FIG.5A, the pull cord 312 may be moved in a proximal direction (as indicatedby the arrow), thus causing the distal flange 304 to change from adelivery configuration to a deployed configuration.

Next, a second force may be applied 606 to an actuator to move a secondportion of the closure element from a first configuration towards asecond configuration. Applying a second force may involve applying asecond force to the actuator to move the proximal portion of the closureelement from a first configuration toward a second configuration. Forexample, and as illustrated in FIG. 5B, the actuator second pusher 320may be moved in a distal direction, thus causing the proximal flange 302to change from a delivery configuration to a deployed configuration.

After the closure element is fully deployed, the closure device may bedisengaged from the closure element and removed from the patient.

The present disclosure may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. The scope of the disclosure is, therefore,indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope. Itshall be further understood that although the present disclosure hasbeen described in relation to vessel closure, it is contemplated thatthe closure component of the present invention may be utilized to closeother openings in the body such as PFO openings, or openings formed inorgans such as the stomach for certain surgical procedures, and/or forclosing fistulae.

What is claimed is:
 1. A method of closing an opening in tissue,comprising: inserting a closure device at least partially through anopening formed in tissue, the closure device including a delivery tube,an actuator, and a closure element, the closure element defined by abody having a proximal portion, a distal portion and a waist; applying aforce to the actuator to move the distal portion of the closure elementfrom a first configuration toward a second configuration; applying asecond force to the actuator to move the proximal portion of the closureelement from a first configuration toward a second configuration.
 2. Themethod recited in claim 1, further comprising engaging the distalportion of closure element with a distal surface of tissue adjacent theopening when the distal portion of the closure element is in the secondconfiguration and prior to moving the proximal portion from a firstconfiguration toward a second configuration.
 3. The method according toclaim 1, further comprising deploying a hemostatic material on oradjacent to the opening in the tissue.
 4. The method recited in claim 1,further comprising disengaging the delivery tube and actuator from theclosure element and removing the delivery tube and actuator from theopening in the tissue.